Study to compare NKTR-102 (also called the study drug) with standard treatments for breast cancer (also called treatment of physician's choice).

Phase 1

• Conditions: Locally Recurrent Breast Cancer, Metastatic Breast Cancer; MedDRA version: 15.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.1 Level: PT Classification code 10006198 Term: Breast cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003832-30-GB
• Lead Sponsor: ektar Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-29
• Study Completion: 2016-04-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 852

Inclusion Criteria

•Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable disease by RECIST version 1.1 or nonmeasurable disease.
•Locally recurrent or metastatic disease that is not resectable or amenable to curative
treatment.
•Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
•Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.Treatment regimens for ipsilateral and/or contralateral recurrent disease (ie, multiple adjuvant therapies) are permitted and all counted as one regimen.
•Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•Adequate hematopoietic, liver and kidney functions.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 672
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

•Patients who have had a last dose of IV chemotherapy within 21 days, last dose of oral cytotoxic chemotherapy, radiotherapy, biological therapy, or investigational therapy within 14 days, or hormonal therapy within 7 days prior to randomization. Patients who have undergone high-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic). Refer to the Study
Reference Manual for categories of anticancer therapies.
•Patient with any major surgery within 28 days prior to randomization.
•Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
•Patient with prior treatment for cancer with a camptothecin derivative.
•Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
•Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
•Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
•Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
•Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
•Patients with significant cardiovascular impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified